Navidea ($NAVB) is banking on its Lymphoseek cancer diagnostic aid to bring in millions in sales, but the company was dealt a blow Monday when the FDA rejected its application, further delaying the launch of the radiopharmaceutical agent.
In its rejection letter, the FDA said its problems were with a third-party contract manufacturer Navidea employed to produce Lymphoseek, not the agent's safety and efficacy data, according to Navidea. CEO Mark Pykett said Navidea is already working closely with the FDA and its contract manufacturer to address the problems and refile for approval as quickly as possible.
"We remain confident that our clinical data clearly demonstrate the value of Lymphoseek in accurately identifying lymph nodes that most likely harbor cancer while producing no clinically significant adverse effects," Pykett said in a statement.
Lymphoseek is designed to bind to the lymph nodes, finding those that drain from a primary tumor in patients with breast cancer or melanoma. That allows physicians to see if the cancer has spread during lymphatic mapping procedures, guiding biopsies and therapy decisions, Navidea says.
Navidea filed for FDA approval back in October, hoping to launch the diagnostic agent in June, but the FDA pushed back its ruling and asked for more information on Lymphoseek's chemistry and manufacturing.
The latest delay could put a damper on Navidea's projected earnings, too, as analysts from ThinkEquity have said Lymphoseek could bring in revenue of $36.5 million next year and grow to $150 million annually by 2016, Columbus Business First reports.
- read Navidea's statement
- check out Business First's story
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